Medical Device with Retractable Needle

ABSTRACT

A tamperproof retractable non-reusable syringe has a one piece hollow outer body with a barrel for a slidable plunger, a transition zone and a smaller diameter nose portion. An elongated needle holder and spring combination is installable from the rear of the outer body, guided into the nose portion and held by cooperating inwardly and outwardly facing surfaces oriented in the direction of retraction at the most constricted part of the transition zone where the nose begins. The plunger has an opening with a dislodgable stopper for receiving parts of the retraction mechanism. The stopper and the head of the needle holder are of significantly reduced diameter from the injection fluid chamber to resist blowing out prematurely. In one embodiment the head of the needle holder is surrounded by a separable retainer member which is slidingly removed by contact with the tip of the plunger after the stopper is mostly or fully removed to avoid cumulation of force required for retraction after the injection. In a second embodiment the head of the needle holder is clamped and held by constricting forces imposed by stress on the outer body induced by interference fit. Release occurs by slight expansion on the barrel by contact of the plunger tip with a small internal ramp in the outer barrel. Both embodiments have a plunger cap configured to enter an opening in the outer body to provide an additional tamperproof feature. The retraction cavity is provided with venting structures to assure that all uninjected fluid is retained within the syringe body.

CROSS REFERENCE TO RELATED APPLICATION

This is a continuation-in-part of copending patent application Ser. No.08/537,242 filed Sep. 29, 1995 entitled Tamperproof Retractable Syringewhich in turn was a continuation of Ser. No. 08/438,954 filed May 11,1995, now U.S. Pat. No. 5,578,011 all by the same inventor for whichbenefit is claimed under 35 U.S.C. §120.

FIELD OF THE INVENTION

This invention relates to a medical device, and more particularly to aretractable syringe and components suitable for mass production andassembly having a low triggering force and high blowout pressure whichis nonreusable after one use.

BACKGROUND OF THE ART

A major cause to the spread of AIDS in the general population is thepresence of IV drug users who share and reuse hypodermic syringes toinject drugs. Infection can be spread from AIDS patients in hospitalsand medical facilities through accidental needle sticks from needlesused on infected patients. Used syringes with extended needles present arisk to medical personnel and sanitation employees and others in thedisposal chain.

The gravity of the threat posed by AIDS and the fact that the mainvector of the spread of the dreaded disease is through reuse of syringesby IV drug users has resulted in intense activity to develop the mostpractical, most reliable, easily assemblable, mass-producible syringe.

There are a number of syringes of different designs which have needleswhich will retract at the end of the injection cycle. Most of these havenever reached the market because of various deficiencies. Prime amongthe usual deficiencies of the prior art are problems of complexity,reliability, cost and ease of use. The most commonly used syringes are 1cc and 3 cc syringes which must be mass-produced at the rate of millionsper day. Cost is a significant factor both in manufacture of the partsand assembly of the device. High speed production requires molds with 64cavities or more to reduce unit cycle time. Therefore, molded structureswithin the barrel that require collapsing core pins such as are shown inmuch of the art are unlikely to be producible at competitive costs.

One of the problems of the prior art of retractable syringes is thesheer number and complexity of parts which must be formed and assembled.Other problems with the prior art are dependence on flexing or breakingof internal parts by the plunger in order to release the retractionmechanism and use of a diaphragm at the end of the plunger which must bepenetrated by a needle holding member and spring. These structurespresent serious quality control and assembly problems. Small broken offpieces can present a risk of hang-ups. Hooks are often used toreleaseably secure retraction mechanisms. Hooks present difficultholding and control problems, may cause retention of air bubbles uponfilling and may be undesirably temperature sensitive.

The prior art frequently has a two-piece barrel in order to be able toassemble a retraction device in the nose. This requires at least anadditional part and assembly step. It is still necessary to pass thesharp injection needle through a small opening often while compressing aspring before the two parts can be assembled. The tiny needles areproduced in the form of coil tubing and vary significantly fromstraightness after they are cut to length. This leads to difficultassembly problems if the needle must be passed through a small opening.The extremely sharp tip will catch the edge of a hole and jam theproduction line.

The rare prior art that employs a front mounted retraction mechanism ina one-piece barrel with a plugged hollow plunger, Tsao U.S. Pat. No.5,084,018, among other things does not show reduced barrel area toprevent excessive blowout pressure, employs engaging flanges to secureall retraction parts, requires concurrent distortion of internal partsand flanges to effect release, cumulating in excessive force required toretract and requires ventilation holes because of a compartmentedbarrel.

The prior art has not produced a retractable nonreusable tamperproofsyringe for mass production and assembly which is simple, reliable, costeffective, easy to use and retract, looks like a conventional syringe,has few parts which are easy to make and assemble, is not temperaturesensitive and not subject to danger of premature retraction.

The prior art has not recognized a retraction mechanism with separableparts that relies entirely on clamping force or friction at a smoothwalled reduced diameter transition zone in the barrel with mating landswhich are slidably or separably released in response to relatively lowthumb pressure while having resistance to premature retraction and highblowout pressure resulting from high pressure produced in the fluidchamber during an injection. The prior art has not recognized that sucha structure can be molded as a one piece outer body over a core that canbe pulled out from behind allowing the retraction mechanism to be easilypushed into place from behind, steered by the narrow nose portion.Neither does the prior art in such a combination realize the desirablenon-cumulation of forces resisting retraction in order to minimize thethumb force required, having a most simple tamperproof feature and thefewest number of easily made parts.

The syringe plunger assembly has a combination of features not found ina prior art syringe. A head end which acts like a piston when installedin a syringe barrel has a reduced diameter front end having an openingand a dislodgeable stopper slidingly mounted in the opening projectingforwardly from the tip. Cooperating lands within the opening and on thehead of the dislodgeable stopper seal the opening into the hollowinterior of the plunger. The area of the stopper is relatively smallwhen compared to the area exposed to the piston, which compresses fluidin a chamber below the piston. The ratio of the total area of the fluidchamber to the fluid exposed area of the stopper is at least two to one,more preferably three to one or more so that the stopper requires lessholding force without blowing out back into the internal cavity. Thecooperating lands have sufficient length so that the stopper can moveback to the tip when the plunger moves forward at the end of aninjection stroke without unsealing the plunger opening. A reducedholding force is sufficient to prevent blowout of the stopper after thestopper has been moved back to the tip because the stopper is exposed toa lower pressure generated force because of its relatively smaller area.The back of the plunger is vented so that entry of retractable partswhich upon retraction finish dislodging the stopper and carry it backinto the cavity, do not generate internal pressure that can blow out thenose of the syringe carrying any residual fluid with it. The thumb capon the plunger is received and recessed into the opening at the back ofthe barrel when retraction occurs. The plunger cannot be grasped afterthis occurs to help prevent reuse.

These features and more are found in the inventive combination hereinfurther disclosed which is especially suited for high speed productionand assembly at low cost.

SUMMARY OF THE INVENTION

The invention is a reliable retractable tamperproof syringe havingmultiple tamperproof features which operates on a principle whichpermits low cost parts which are few in number and well suited for highspeed mass production and assembly. The syringe structure features a onepiece hollow outer body having a longitudinally extending wall which isstepped. The wall comprises an elongated barrel and nose with atransition zone connecting the barrel and nose. The nose has a reduceddiameter relative to the barrel. The outer body has an inwardly facingsurface in the wall at the most constricted part of the transition zonewhere the nose begins. A plunger assembly is disposed partially withinthe elongated barrel with an end cap for depression of the plungerextending from an opening in the back of the barrel. The head of theplunger, which has a retraction cavity for receiving parts of aretraction mechanism, moves in slidable sealed contact with the interiorof the barrel.

A retraction mechanism is lodged in the nose of the body. The retractionmechanism comprises an elongated needle holder and spring combinationwherein the needle holder has an elongated body with a needle holdingportion in front and a head in back. The head of the needle holder has acooperating outwardly facing surface configured to cooperate with saidinwardly facing surface along an interface oriented in the direction ofretraction to produce a holding force on the needle holder wheninstalled in the nose in the unretracted position. The needle holder andspring are easily installable from the rear of the barrel toward thenose and releaseably held by sliding engagement of said cooperatinginwardly and outwardly facing surfaces while compressing the spring andthereby producing a holding force on the needle holder in opposition tothe retraction force applied to the needle holder by the spring. Theparts are circular in cross section.

The outwardly facing surface on the circular head of the needle holderis slightly greater in diameter than the circular inward facing surfacein the wall at the most constricted portion where the nose begins. Theneedle holder is thus clamped in position by hoop stresses induced inthe outer body and held in position by frictional holding force. Theneedle holder is released in response to depression of the plunger to aretraction position. Retraction occurs in response to thumb force on theplunger when a portion of the plunger passing into the transition zoneseparates at least a portion of the inwardly and outwardly facingcooperating surfaces thereby reducing the holding force on the needleholder to an amount less than a retraction force on the needle holderproduced by the spring whereby the needle holder is retracted into thecavity a distance sufficient to withdraw an injection needle, attachedto the needle holder, into the outer body.

In one embodiment, the head of the needle holder is a two part headcomprising an inner head surrounded by a separable retainer memberwherein the outer surface of the retainer member is the outwardly facingsurface with cooperates with the inwardly facing surface in the wall toretain the needle holder in an unretracted position at the mostconstricted part of the transition zone where the nose begins. Theretainer member is a ring member coupled to the inner head along asliding interface oriented in the direction of retraction with afriction force which exceeds the retraction force provided by thespring. The front of the needle holder is grounded in the nose portionagainst forward movement. The plunger head is configured to pass throughthe most constricted area and push against the retainer member withoutalso pushing against the head of the needle holder. An alternateconstruction of the two part head of the needle holder comprises theseparable retainer member being tack welded to the inner head of theneedle holder, preferably along a very small ridge or bridge between themating surfaces which holds the two part head together until the bridgeis ruptured by movement of the plunger after an injection has occurred.

The front of the plunger has an opening for a stopper slidingly fittedtherein in an interference fit. The stopper is fitted in the opening inan interference fit along a sliding interface oriented in the directionof retraction. The stopper is mostly or fully dislodged by contact withthe retraction mechanism at the end of an injection cycle by continueddepression of the plunger from a first position at the end of theinjection cycle to a second position with the tip of the plunger incontact with the retainer ring. This avoids cumulation of the force onthe plunger required to dislodge the stopper from the opening and theforce required to dislodge the retainer member from the head of theneedle holder and outer body wall. Upon further depression of theplunger from the second position to the retraction position, thefrictional holding force on the needle holder is reduced until theretraction force provided by the spring exceeds the remaining holdingforce and the needle holder and needle connected thereto are ejectedinto the cavity carrying the dislodged stopper along with them. Thedislodging of the stopper and the retainer member alone make the syringenon-reusable. The plunger cannot be removed after retraction because thegraspable end cap enters an opening at the back of the barrel when theplunger is depressed to the retraction position to prevent tamperingafter retraction.

The retraction cavity of the plunger is preferably vented to prevent apuff of air coming forward at the instant of retraction from blowing atiny amount of retained fluid from the nose. This condition can occur ifthe plunger is fully depressed to release the needle holder and dislodgethe stopper while the needle is physically restrained from retracting bythe septum of a vial which has just been filled with fluid from thesyringe. The thumb cap at the rear of the syringe is preferably providedwith channels in fluid communication with the interior in cooperationwith a closure removably installed in a centrally located opening in thethumb cap. One or more stepped portions of the opening and closureprovide seating for the closure. Undercut portions at the side of theclosure together with grooves in the interior surface of the plungerwall create passages for air to vent through channels on the thumb cap.This structure prevents air from being trapped by the user's thumb whenthe thumb cap is pressed to fire the syringe. One or more slots at theback of the barrel around the opening which receives the thumb capprevent vented air from being trapped by the user's thumb when theplunger is fully depressed.

The syringe has a high blowout pressure and a low plunger thumb forcerequired to cause retraction. Blowout pressure is the fluid pressureoperating on the stopper and retainer ring during an actual injection.High blowout pressure resistance is obtained because the retainer ringis mounted in the most constricted portion of the barrel where the nosebegins which significantly reduces the amount of area exposed to fluidpressure. The smaller retainer ring allows the use of a small needleholder such that the opening in the plunger and the stopper can be onlya fraction of the cross sectional area of the fluid chamber below theplunger head. The ratio of the greatest cross sectional area of thevariable chamber and that of the dislodgeable stopper or the ring memberare selected so that the maximum expected thumb force on the plungerduring an injection will produce a maximum pressure in the chamber whichwill generate a blowout force on the stopper and retainer memberslightly less than the amount of dislodging force necessary to dislodgethe stopper and retainer member during retraction. This ratio should beat least two to one, or more preferably three to one or more, in orderto ensure against premature blowout of the stopper or retainer ring.

In an alternate embodiment, the fewest number of easily made separateparts are used in a retractable syringe. The alternate embodiment has asimilar stopper in the head of the plunger and a similar needle holderand spring combination with mating cooperating inwardly facing andoutwardly facing interengaged surfaces at the most constricted part of atransition zone where the nose begins. In the alternate embodiment,there is no retainer ring around the head of the needle holder. Insteada tiny ramp is provided at the transition zone or adjacent thetransition zone whereby the head of the plunger gently spreads thebarrel outwardly while dislodging the stopper thereby reducing theclamping or friction force on the head of the needle holder provided bythe wall of the outer body. The holding force is thereby reduced belowthe retraction force provided by the compressed spring and the needleholder is ejected into the cavity of the plunger carrying the dislodgedstopper along with it.

Manufacture and assembly is facilitated by the fact that the plunger andthe outer body can be molded with a non-collapsible core tool that canbe pulled out from behind. The parts are simply shaped and do not havehooks and parts with reentrant angles that require collapsible core pintechnology. The outer body can be made in one piece and assembled fromthe rear. The narrowed nose portion provides no lateral space with willpermit bunching of the spring and jamming when the retraction assemblyis moved forward in the outer body. In fact, the nose serves as a guideto steer the parts into the proper position in one smooth stroke.

The needle does not have to be installed before the retraction mechanismis put in place because it is readily installed from the front after theneedle holder is slidingly lodged in the nose. Significant variations inthe holding force on the needle holder and the dislodging force on thestopper due to slight variances in the tolerance of the mating parts isavoided because the longitudinal wall of the outer body has someflexibility. The wall can spread outwardly slightly and the stopper andhead of the needle holder can compress slightly radially and expandslightly in the longitudinal direction to avoid significant changes inthe holding force caused by small changes in the actual diameters.Consistency in the amount of retraction force is thereby provided andeconomy is assured.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross section along the central axis of a first embodimentof the invention with the plunger positioned in a first position at theend of an injection cycle;

FIG. 2 is the syringe of FIG. 1 with the plunger depressed additionallyto dislodge the stopper at a second position of the plunger wherein thetip of the plunger is ready to operate the retraction mechanism;

FIG. 3 is the syringe of FIG. 2 wherein the plunger has been furtherdepressed to a retraction position, retraction has occurred and the capat the back of the plunger is closely received in an opening at the backof the outer body;

FIG. 4A is a partial cross section on the central axis of an alternatetamperproof opening in the back of the outer body prior to retraction;

FIG. 4B is the structure of FIG. 4A with the plunger in the retractedposition received in an opening at the back of the outer body;

FIG. 5 is a cross section along the central axis of a simplifiedalternate syringe structure without a retainer member around the needleholder, which is released by separation of the friction surfaces, shownin the plunger position which represents the end of injection cycle;

FIG. 6 is the syringe structure of FIG. 5 wherein the plunger is furtherdepressed to dislodge the stopper and begin to release the frictionsurfaces just prior to retraction;

FIG. 7 is the syringe structure of FIG. 6 with the plunger furtherdepressed beyond the position of FIG. 6 to the retraction position whereretraction has occurred and the cap is secure within an opening in theback of the hollow outer body.

FIG. 8 is a schematic longitudinal cutaway view in elevation through thecenter of the two part head showing how a tack weld can be applied tosimultaneously seal and hold the retainer ring in place on the needleholder.

FIG. 9 is an exploded perspective view showing the barrel and retractionmechanism of FIG. 1 with a modified plunger assembly;

FIG. 10 is a plan view of the thumb cap of the plunger assembly shown inFIG. 9 with the preferred closure;

FIG. 11 is a cut away elevational view of the structure at the back endof the plunger and end cap of FIGS. 9 and 10 along line 11-11 showingthe preferred closure;

FIG. 12 is a cut away elevational view of the plunger end cap andclosure of FIG. 11 as the thumb cap is just being received into thebarrel opening;

FIG. 13 is a plan view of a first alternative thumb cap and closurecombination utilizing a flat sided closure and four channels in thethumb cap;

FIG. 14 is a cut away elevational view on the lines 14-14 of the thumbcap closure combination of FIG. 13;

FIG. 15 is a plan view of a second alternate thumb cap and closurecombination with four channels in the thumb cap and undercut portions toprovide a vent passage;

FIG. 16 is a cut away elevational view on the lines 16-16 of thecombination of FIG. 16.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

In the description that follows, like parts will be referred to by thesame reference numerals. Parts with a subscript letter are mean toillustrate a minor variation of a part with the same number. Thedrawings are enlarged significantly in order to show the details of theinvention but generally reflect the true scale which is contemplated.The parts as shown are understood to be preferably circular andsymmetrical as is conventional for syringes. The drawings reflect asyringe structure typically having a 1 cc to 3 cc injection fluidcapacity.

FIG. 1 shows the structure of the first embodiment generally referred toby reference numeral 10. Syringe 10 has a one piece hollow outer body12. Body 12 has a longitudinally extending wall comprising an elongatedbarrel 14 and a nose 16 with a transition zone 18 connecting the barreland nose. A front mounted retraction mechanism lodged in the nose isgenerally referred to by the reference numeral 20. It comprises thecombination of an elongated needle holder 22 and spring 24. The needleholder has an elongated body with a needle holding portion 26 in frontfor holding a needle 28 and a head 30 in back. Head 30 may consist of atwo part head as in FIGS. 1-3 or a one part head as in FIGS. 5-7. Theneedle holder is released by depression of a plunger that will bedescribed.

A plunger generally designated by the reference numeral 32 is disposedfor use partially within barrel 14. The plunger has a head and sealgenerally referred to by reference numeral 34, in slidable sealedcontact with the interior of barrel 14 of outer body 12. The plunger hasa seal element 36 that is conventional and a retraction cavity 38therein.

Head 34 has a tip portion 40 forming an opening 41 into retractioncavity 38. A resilient dislodgable stopper 42 is sealingly positioned inopening 41 with a front portion thereof extending beyond tip 40. Headportion 34 and the back part of stopper 42 have cooperating lands 44,46, respectively, which seal opening 41. Plunger 32 has an end cap 48for depression of the plunger by the thumb. End cap 48 has a centralopening for permanently receiving force fit plug 50 to close retractioncavity 38 at the back end.

A plurality of longitudinally extending flutes 52 slidingly supportplunger 32 in barrel 14. In the embodiment of FIG. 1, outer body 12 hasa collar 54 extending behind finger grips 56 having opening 58 whichclosely receives the outer periphery 60 of cap 48 when the plunger isdepressed to the retracted position. An alternate arrangement is shownin FIGS. 4A and 4B in which barrel 14 is extended longitudinally, ifnecessary, so that end cap 48 fits closely within an opening at the backof the barrel where the finger grips are. FIG. 4B shows the tamperproofposition with the plunger in the retracted position. It should be notedthat depending on the relationship of the inside diameter of the barreland the diameter of the end cap, the end cap could instead be receivedright inside the opening at the back of the barrel. Regardless of howthe end cap in back of the outer body and barrel are configured, theplunger can no longer be grasped after retraction has occurred becauseend cap 48 is depressed into an opening.

The wall of outer body 12 and head 30 of the needle holder have matingcooperating smooth surfaces which hold needle holder 22 in the positionshown in FIG. 1 with spring 24 compressed. Nose 16 has a reduceddiameter relative to the barrel. The outer body has a most constrictedpart where head 30 of needle holder 22 is engaged and held. The outerbody has an inwardly facing surface 62 at the most constricted part ofthe transition zone where nose 16 begins. Similarly, head 30 has anoutwardly facing surface 64 configured to cooperate with inwardly facingsurface 62 to produce a holding force on needle holder 22 when theretraction mechanism is installed in the nose from the rear. Matingsurfaces 62, 64 constitute a sliding interface oriented in the directionof retraction, which seals nose 16. Mating surfaces 62, 64 arepreferably friction surfaces which have an interference sliding fit toapply a frictional holding force which holds needle holder 22 inposition by friction between the mating parts. It is withincontemplation of the invention that one or more of the cooperatinginterface surfaces could employ a coating or adhesive bond which isruptured or released when the mating surfaces or lands are separated ormoved relative to each other.

Head 30 provides a lower boundary for a variable fluid chamber 68 belowhead 34. Needle holder 22 has a fluid path 70 in fluid communicationwith fluid chamber 68 and needle 28. Needle holder 22 has a smallerdiameter inner head 72 which is part of head 30. Retainer member 66 iscoupled to inner head 72 along sliding interface 74 oriented in thedirection of retraction. Retainer member 66 is coupled to inner head 72with a holding force which exceeds a retraction force applied to theunderside of inner head 72 by means of the end of compressed spring 24.A reduced diameter portion 27 of needle holder 22 protrudes through anopening in front 76 of nose 16.

Importantly, retainer member 66 can be visualized as an annular ringsurrounding circular inner head 72. The location of retainer member 66at the most constricted part of the transition zone where the nosebegins and the relatively small area exposed to pressurized fluid inchamber 68 results in a high blowout pressure. Since the front portion26 of the needle holder is grounded or bottomed inside front 76 of nose16, no amount of pressure will allow needle holder 22 or needle 28 tomove forward. Blowout pressure may be defined as the pressure in chamber68 acting on the exposed area of retainer member 66 to produce a forcesufficient to overcome the holding force such that retainer 66 could“blowout” by moving forward and prematurely release needle holder 22.

Some users have strong hands and might, at the outer limit in anemergency, be able to generate a force of as much as fifteen to eighteenpounds on the plunger during an injection. It is considered almostimpossible for anyone to exert a force of more than eighteen pounds.This may be regarded as the maximum expected force which must be takeninto account so that ring member 66 will not blowout while an injectionis being made. The greatest cross sectional area of variable chamber 68and the area of retainer member 66 exposed to fluid pressure areselected so that the blowout pressure is higher than the maximumpressure in chamber 68 expected to result from the maximum expectedthumb force applied to cap 48 during an injection. This ratio ispreferably about two to one and more preferably about three to one ormore so that the holding force holding the retraction mechanism in placecan be kept at a comfortably low level while the blowout pressureremains high.

Dislodgeable stopper 42 has a similar blowout problem to recognize. Thefront and middle portion of stopper 42 are relieved slightly fromopening 41 such that the fluid pressure in chamber 68 is directedagainst the cross sectional area at cooperating lands 44, 46 and couldcause stopper 42 to blowout. A frictional holding force is generated atthe lands 44, 46 which may be called a dislodging force which must beovercome to slide stopper 42 rearwardly before retraction. The ratio ofthe maximum cross sectional area across the interior of variable chamber68 to the maximum cross sectional area of stopper 42 exposed to pressurein chamber 68 are selected so that the maximum expected thumb force onplunger 32 during an injection will produce a maximum force slightlyless than the amount of dislodging force necessary to dislodge thestopper so that stopper 42 will not blowout during an injection. Thisratio is preferably not less than about two to one, more preferablythree to one or more, whereby a force of about eighteen pounds on theplunger, for example, would produce a pressure generated force of onlyabout nine or six pounds, respectively, on the stopper, so that thestopper can be easily dislodged in advance of retraction at the end ofthe injection cycle but will not blowout during an injection. Thestopper is dislodged after the injection by thumb force applied to thestopper by movement of the plunger.

The components used for retraction are arranged to avoid cumulation offorce during the retraction sequence. In FIG. 1, stopper 42 has aforward extension beyond tip 40 which allows full thumb pressure to beapplied to the stopper before any other portion of the retractionmechanism is engaged. The amount of forward extension beyond tip 40 isrelated to the length of lands 44, 46 such that the forward extension ofstopper 42 preferably represents about 80 percent of the engaged landlength. When stopper 42 is moved back until the front is even with tip40, as seen in FIG. 2, only about 20 percent of engaged land remains. InFIG. 2 it can be seen that thumb force on plunger cap 48 has beenapplied to partially dislodge stopper 42 such that a gap 78 is createdand the remaining engaged land area is represented as area 80.

Since I believe the amount of frictional holding force or dislodgingforce is roughly proportional to the amount of the length of the slidinginterface between cooperating lands 44, 46, it follows, ignoring dynamiceffects, that the amount of force remaining decreases as the engagedsliding interface area is reduced. This is what happens as stopper 42moves back into cavity 38 from the position of FIG. 1 to the position ofFIG. 2. It is believed appropriate to set the initial dislodging forceto allow about five pounds at the position of FIG. 1 which is reduced toabout one pound remaining when the stopper or plug member 42 reaches theposition of FIG. 2. It might be noted at this point in the descriptionthat the front portion of tip 40 preferably has some longitudinallyextending slits or openings so that fluid is not trapped in thetrapezoidal shaped area of chamber 68, seen in FIG. 2, because ofcontact between tip 40 and the upper surface of retainer ring 66.

Needle holder 22 and spring 24 are combinably installable from the rearof the barrel before the plunger is assembled and releasably held at themost constricted part of the transition zone where the nose begins bysliding engagement of the cooperating inwardly and outwardly facingfriction surfaces 62, 64 while compressing spring 24. The length of theengaging land 64 and the amount of interference fit is preferablydesigned to provide a frictional holding force in opposition to theretraction force provided by the compressed spring 24 of somewherearound five pounds even though the spring may apply a retraction forcein the retraction direction of somewhere around a half pound. In use theneedle is pushed against a rubber seal in a vial so the needle holdermust resist a resulting backward force without being dislodged duringthe filling operation. This requirement and blowout pressure limits thelow end of the holding force on the needle holder.

Referring again to FIG. 2, it can be seen that further depression of theplunger beyond the second position of FIG. 2 dislodges retainer ringmember 66 along the sliding interface 74 provided by the outer surfaceof inner head 72 and along the inwardly facing friction surface 62. Asthe amount of remaining engaged interface is reduced, the amount offorce required to continue moving retainer member 66 off needle holder22 is reduced and the small remaining engagement area 80 between lands44, 46 of the plunger and stopper preferably cause stopper 42 to bedislodged before needle holder 22 is released. When the remainingresidual friction force during continued depression of the plungerbecomes less than the retraction force provided by compressed spring 24,the retraction position of FIG. 3 is reached whereby retraction occurs.

When retraction occurs needle holder 22 moves through opening 41 intocavity 38. The uncompressed length of spring 24 is selected to providebackward movement sufficient to withdraw an injection needle 28 fixed infront portion 26 entirely within outer body 12, carrying dislodgedstopper 42 with it. At the same time, cap 48 enters opening 58 of thebarrel with peripheral edge 60 closely confined, in order to preventtampering after retraction. It is immaterial whether cap 48 moves intothe opening at the instant of retraction or after retraction has alreadyoccurred because the movement is automatic due to the continued thumbforce applied to trigger the retraction. Sufficient unengaged length ofinwardly facing friction surface 62 is provided so that retainer member66 can move downwardly a sufficient distance to reach the retractionposition of FIG. 3. After retraction, retainer member 66 preferablyremains stuck and prevents any possibility of any one being able toreengage it with the head of needle holder 22. The diameter of land 62in the area designated 63 can be increased slightly to provide relieffor retainer ring 66 as it is pushed down by tip 40.

It is also within the contemplation of the invention that separableretainer member 66 may be removably coupled to inner head 72 of needleholder 22 by means of a relatively small in area “tack” weld which issufficient to resist the retraction force applied to needle holder byspring 24 but which can be ruptured or separated by depression of theplunger beyond the position shown in FIG. 2, to release the needleholder and allow retraction. This is schematically illustrated in FIG. 8with respect to alternate head 30 a with the parts of syringe body 12and needle holder 22 cutaway to focus on the modification. The remainderof the syringe structure would be like FIGS. 1-3.

In FIG. 8, inner head 72 a has an outwardly facing surface 74 a and avery small raised portion or series of horizontally spaced apart raisedportions 73 around the periphery in a continuous band or annular ringwhich extend relatively uniformly outwardly beyond peripheral surface 74a of head 72 a. The raised portion could be on the inner surface 75 ofretainer 66 a instead of being on surface 74 a of the needle holder. Thehead of the needle holder is preferably circular but could beconceivably another shape with the retainer member 66 a correspondinglyconfigured to conform to it.

The inwardly facing surface 75 of inner head 72 a is in contact withraised portion 73 on the outer surface of inner head 72 a and there maybe a small gap 77 between them all around. The raised portion 73 couplesretainer 66 a to inner head 72 a and may be referred to as a bridgingportion which resists the blowout pressure referred to above and holdsthe needle holder in place against the retraction force imposed on theneedle holder by spring 24 together with any small additional forcesthat may be applied when the needle is pushed against the rubber seal ofa vial in preparation for use. The bridging portion may be formed by“tack” welding the raised portion 73 to the inner surface of the ring 66a or by providing any other form of frangible bridging portion thatholds the separable ring member 66 and needle holder head 72 a together.It is required that however done, the bridging portion must also serveas a seal between the facing surfaces of the ring member and inner headso that fluid under pressure cannot pass from chamber 68 through gap 77to reach the nose portion of the device. All fluid must pass throughfluid passage 70.

It can be seen that when the position of FIG. 2 is reached the front tip40 of the plunger presses against retainer ring 66 a after stopper 42 isalmost dislodged and uncouples the retainer ring 66 a from the innerhead 72 a of needle holder 22 a. Any tack weld connecting the separableparts at the bridging portion is ruptured, fractured or otherwiseseparated so as to separate retainer ring 66 a from inner head 72 a thusreleasing needle holder 22 a from further restraint. They and the forceapplied by spring 24 causes retraction to occur much as before describedand shown in FIG. 3.

It is believed that the increased diameter of the raised portion 73should be within the range of about 1 to 8 thousandths of an inch whichmay be dictated by the ability of the molding equipment available toproduce a consistent bridging portion without defects. It is believedthat it may be desirable to employ different polymeric materials for theretainer ring and needle holder to facilitate tack welding, such as asuitable polyvinyl chloride (PVC) for the retainer ring and a suitablepolycarbonate plastic material for the needle holder. One way to couplethese two parts may be to assemble them and expose them to a temperatureof about 120° C. for twenty minutes or so to allow some diffusion orincipient melting to occur where they touch. The raised portion createsa high unit pressure where it comes into contact with the inwardlyfacing surface of retainer 66 a. Sonic welding could also be employed. Acoating or adhesive which couples the retainer ring to the needle holderand can be uncoupled by means of force applied to the retainer ring bythe plunger is also within the contemplation of the invention.

An alternate syringe 82 is disclosed in FIGS. 5-7. In FIG. 5, Syringe 82has a one piece hollow outer syringe body 84. Body 84 has alongitudinally extending wall comprising an elongated barrel 86 and anose 88 with a transition zone 90 connecting the barrel and nose. Afront mounted retraction mechanism lodged in nose 88 is generallyreferred to by the reference numeral 92. It comprises the combination ofan elongated needle holder 94 and spring 96. The needle holder has anelongated stem body with a needle holding portion 100 in front forholding needle 28 and a head 102 in back. In this case, head 102 is aone part head integral with the rest of needle holder 94. Spring 96delivers a retraction force in a retraction direction to the undersideof head 102.

A plunger generally designated by reference numeral 104 is disposed foruse partially within barrel 86. Plunger 104 has a head portion 106 whichmoves in slidable sealed contact with the interior of barrel 86 of outerbody 84. Although a separate seal might be used on head 106, thisembodiment is suitable for a smaller diameter, such as a 1 cc syringe,and can be used with head 106 also serving as the seal. A retractioncavity 108 is provided in the interior of hollow plunger 104. Head 106has a tip portion 110 forming an opening 112 for a dislodgable stopper114 having a front portion extending beyond tip 110. Head portion 106has an inwardly facing land 116 and the back of stopper 114 has anoutwardly facing land 118 comprising cooperating friction surfaces whichseal opening 112. The back portion of outer body 84 may have fingergrips 120 and the same collar 54 and end cap 48 previously disclosed.The alternate arrangement of FIGS. 4A and 4B may also be employed.

The outer portion of tip 110 may be equipped with an angled surface 122designed to cooperate with a small ramp surface 124 located in thevicinity of transition zone 90. The wall of outer body 84 and head 102of the needle holder have mating cooperating friction surfaces whichfrictionally hold needle holder 102 in the position shown in FIG. 5 withspring 96 compressed. Nose 88 has a reduced diameter relative to barrel86. The outer body has a most constricted part where the head 102 ofneedle holder 94 is frictionally engaged. The outer body has an inwardlyfacing surface or land 126 at the most constricted part of thetransition zone where nose 88 begins. Similarly, head 102 has anoutwardly facing friction surface 128 configured to cooperate withinwardly facing surface 126 to produce a frictional holding force onneedle holder 94 when the retraction mechanism is installed in the nosefrom the rear.

Mating surfaces 126, 128 constitute a sliding interface oriented in thedirection of retraction, which seal nose 88. Mating surfaces 126, 128are preferably smooth friction surfaces which have an interferencesliding fit when needle holder 94 is installed from the rear whereby africtional holding force holds needle holder 94 in position by frictionbetween land 126 and head 102 of needle holder 94. It is withincontemplation of the invention that one or both of these surfaces couldhave a coating or adhesive bond which is ruptured when the matingsurfaces are separated to release the needle holder.

Head 106 provides the upper boundary for a variable fluid chamber 130below head 106. Needle holder 94 has a fluid path 132 in fluidcommunication with chamber 130 and needle 28. Needle holder 94 isreleasably coupled at surfaces or lands 126, 128 with a holding forcethat exceed the retraction force applied to the underside of head 102 bythe end of compressed spring 96. A reduced diameter portion 134 ofneedle holder 94 protrudes through an opening in front 136 of nose 88.Blowout pressure is not a factor with respect to the needle holder onthe alternate embodiment. No amount of pressure will allow needle holder94 or needle 28 to move forward since the front portion 100 of theneedle holder is grounded or bottomed inside front 136 of nose 88.

Blowout pressure is still a factor to be considered in connection withstopper 114. Blowout pressure would be the pressure in chamber 130produced by thumb force on cap 48 acting on the cross sectional area ofstopper 114 which could overcome the holding force, causing stopper 114to dislodge from opening 112 prematurely. The ratio of the maximum crosssectional area across the interior of variable chamber 130 to themaximum cross sectional area of stopper 142 exposed to pressure inchamber 130, and the dislodging force necessary to dislodge stopper 144,are selected so that the maximum expected thumb force on plunger 104during an injection will not cause the stopper to blowout. Yet thestopper will still be dislodged by the dislodging force on the plungeronce the front of stopper 114 contacts the retraction mechanism afterthe injection has ended. The ratio referred to is preferably not lessthan about two to one, or more preferably about three to one or more,whereby a force of about eighteen pounds on the plunger, for example,would produce a pressure generated force of only about nine or sixpounds respectively, on the stopper, so that the stopper can be easilydislodged in advance of retraction at the end of the injection cycle butwill not blowout during an injection. The smaller diameter stopperallows two or three times the thumb force to be used during theinjection cycle than required to actually dislodge the stopper by directapplication of force.

By reference to FIGS. 5-7, the operation and further features of thealternate embodiment are discussed. The syringe is used in the normalmanner until the plunger is depressed to the first position of FIG. 5which is the end of the injection cycle. Stopper 114 has a forwardlyextending end which has come into contact with head 102 of needle holder94 to block fluid path 132. Further depression of plunger 104 toward theposition of FIG. 6 mostly or fully dislodges stopper 114 and beginsspreading barrel 84 at the transition zone by sliding contact betweenhead portion 106 and ramp 124. Ramp 124 is a very small inwardlyextending annular thickening of the wall of barrel 86 which can takemany shapes or forms. For example, ramp 124 may be a small step 125 inthe wall which continues vertically downward as indicated by the dottedline, which is somewhat exaggerated in FIG. 5.

The barrel is flexible and is spread outwardly a slight amount to theposition of FIG. 6 just prior to retraction. Here the mating surfaces126, 128 are separated an amount which reduces the clamping force on theneedle holder 94. The spreading shown in FIG. 6 is greatly exaggeratedfor illustration. It is estimated that an expansion of only about fourthousandths of an inch is sufficient to release needle holder 94 fromnose 88. By slight further depression of the plunger from the positionof FIG. 6 to the retracted position of FIG. 7, retraction occurs whenthe retraction force applied by spring 96 exceeds the remaining holdingforce on needle holder 94. Needle holder 94 then moves through opening112 into cavity 108 along with a portion of spring 96. The uncompressedlength of spring 96 is designed to provide sufficient backward movementto withdraw an injection needle 28 fixed in front portion 94 and carrydislodged stopper 114 with it. At the same time, cap 42 enters opening138 at the rear of a barrel extension 54 where the peripheral edge isclosely confined in order to prevent tampering after retraction.

The location and configuration of ramp 124 is arranged to avoidcumulation of force required during the retraction sequence. Most ofstopper 114 should be dislodged by thumb pressure on plunger 104 beforesignificant resistance develops as angled surfaces 122 begin pushingoutwardly on ramp 124. The selection of the location of ramp 24 and theangle of the engaging surfaces make it possible to have a fairly smoothcontinuous force since the dislodging force continuously decreases asthe sliding interface area 116, 118 between the plunger and the stopperis linearly decreased. Because ramp 124 is relatively very small, it isstill possible to remove a stepped molding core from the rear of theouter body 84. Alternately, ramp 124 can be the smaller diameter step125 which avoids reentrant angles whereby resistance to removal of themolding core could occur. After retraction, the back of the plunger isunaccessible and there is no way to reach to stopper or the needleholder in order to reinstall them for re-use.

When used normally, syringe 10 may have a small amount of fluidremaining in the variable chamber in the second position shown in FIG. 2which is, of course, greatly exaggerated in scale. This may amount to nomore than a drop or a few drops of fluid in the remaining space abovethe retraction mechanism. When syringe 10 is fired by pushing down onend cap 48, to the position of FIG. 3, the expanding spring andrearwardly moving needle holder carry any remaining fluid up intoretraction cavity 38. Surface tension effects hold the tiny droplets inplace along the walls of the plunger and no fluid escapes from nose 16.The syringe is normally used to withdraw fluid from a vial. The fluid isinjected into a patient followed by immediate retraction of the needleholder and needle in one step. No leakage of fluid from the nose isobserved when the syringe is used to inject fluid into a patient.

It has been discovered, however, that if the needle is forciblyprevented from retracting after syringe 10 is “fired” by pushing downuntil plunger 48 enters opening 58, the small amount of retained fluidfrom variable chamber 68 can flow into the nose in the space between theneedle holder and nose. If the seal around the head of the needle holderis removed while the needle holder is being restrained from retracting,remaining fluid has time to move down into the nose, but it does notleak out from the opening in the front of the nose. Then if the needleholder is suddenly released and allowed to retract normally, it has beenfound that leakage of fluid from the opening in the front of the nosecould be observed. This undesirable scenario was found to occur underthe following circumstances. If the syringe is used to draw blood fromthe patient, the blood filled syringe is removed from the patient andthe needle passed through a rubber septum in a sterile vial. The plungeris then depressed to discharge the patient's blood into the vial. Usersexpect to depress the plunger fully after the fluid is discharged toretract the needle. When the plunger is depressed fully to causeretraction, the needle cannot retract normally due to the fact it isfrictionally held by the rubber septum of the vial. When the emptysyringe is then withdrawn from the vial by pulling the needle out of theseptum, it immediately retracts. Droplets of fluid were observed on thevial as soon as retraction took place.

Surprisingly, it was found that a small “puff” of air is the source ofthis problem. If the needle or needle holder is temporarily restrainedand prevented from retracting in the normal manner, a brief puff offorwardly directed air is generated when the needle holder is finallyallowed to retract. This puff of air was found to emerge from the frontof the syringe causing retained fluid trapped around the needle holderto be blown out of the opening left in the nose when the needle holderretracts. It was discovered that if the hollow interior of the plungeris vented, preferably in the area of thumb cap, this condition does notoccur and the fluid is entirely retained within the syringe body.

FIGS. 9 through 16 illustrate the syringe generally designated assyringe 10 with a modification on the end cap or thumb cap on theplunger to provide for venting of the hollow interior of the plungerwhich is the retraction cavity. Insofar as possible the originalnumbering of FIGS. 1-4 is retained with primes used to indicatedifferences.

Head 34′ of plunger 32′ is preferably slightly modified from plungerhead 34 of FIG. 2 in the following respects. The elongated plunger has alongitudinally extending generally tubular wall 140 defining a hollowinterior along the length of the plunger. The plunger has a head end 34′in front and a rear end portion 142 with a thumb cap 48′ behind. Theouter side of wall 140 at head end 34′ is sealingly surrounded with aresilient plunger seal member 36′ which is like a band with a pair ofseparated raised rings 144. Plunger seal 36′ fits in a depression in theouter surface of wall 140 where it is securely held in position andprevented from longitudinal movement. Seal member 36′ is adapted toslide in sealed contact with a tubular wall when the plunger is movedwithin syringe barrel 14. It is within contemplation of the invention tohave a raised piston molded as part of the plastic plunger to serve as aplunger seal in place of a separate rubber plunger seal 36′, althoughthe rubber seal member is preferred.

Wall 140 at head end 34′ of the plunger 32′ has a reduced diameter frontportion extending forward from seal member 36′ terminating at tip 40 atthe front of plunger 32′. Tip 40 defines the opening 41 which leads intothe hollow interior 38. The internal structure is as shown in FIG. 1.The wall 140 behind tip 40 has a stepped inner side surface comprising aland having an inwardly facing surface and a larger diameter portionextending behind the land into the hollow interior. A separatedislodgeable stopper 42 is slidingly held within the reduced diameterfront portion of plunger head 34′ by a holding force in excess of thefluid injection pressure force to be expected during use of the plungerin syringe barrel 14. Stopper 42 has a back end portion comprising aland 46 and a reduced diameter front end portion extending forwardlybeyond tip 40 a fixed distance to its front 146. The fixed distance isthe distance between front 146 and tip 40.

As is seen in FIG. 1, the outwardly facing surface 46 of dislodgeablestopper 42 is in sliding sealed engagement with the inwardly facingsurface of land 44 in the plunger wall. These lands cooperate to apply aholding force to the stopper and seal hollow interior 38 of plunger 32′from the expected amount of fluid injection pressure force generated inthe variable chamber 68 during an injection. The ratio of the effectivearea of variable chamber 68 to the area of stopper 42 exposed to fluidpressure is at least two to one and preferably three to one or more aspreviously indicated. This makes it possible to utilize lower holdingforces without blowing out the stopper during an injection. Thecooperating lands on the inside of the plunger head and the stopper havesufficient longitudinal length to allow dislodgeable stopper 42 to movethe fixed distance between its initial extension at 146 and tip 40 insliding response to forward movement of the plunger after front 146 ofstopper 42 contacts a stop.

As indicated in FIGS. 1-3, front 146 of the stopper 42 encounters head72 of needle holder 22 which serves as a stop. The fluid opening in head72 of needle holder 22 is preferably provided with some fine slots orgrooves so that fluid can continually enter fluid path 70 as the plungermoves from the position of FIG. 1 to that of FIG. 2. As the position ofFIG. 2 is reached, the holding force on stopper 42 is reduced bysubstantial disengagement of the cooperating lands 44, 46 in preparationfor dislodgement of the stopper, without unsealing the hollowinterior/retraction chamber 38 within plunger 32′. A notch 148 ispreferably provided in the tip to prevent trapping fluid at the tip.

Thumb cap 48′ at the rear end portion 142 of plunger 32′ includes one ormore channels 150 which receive vented air from hollow interior 38.Thumb cap 48′ has an opening 152 for a closure 154 best seen in FIGS. 10and 11. Channels 150 are open at the top for ease of molding althoughclosed channels could also be used.

FIG. 10 shows an enlarged top plan view illustrating the use of threechannels 150 in combination with a preferred closure 154 installed incircular opening 152. FIG. 11 best shows how the channels 150 receivevented air from hollow interior 38. Closure 154 preferably has a steppedouter surface comprising a rear step 156 which rests in opening 152, anintermediate step 158 which rests in an enlarged portion 160 of theinner side of wall 140 and a front step 162 which rests against innersurface 164 of wall 140. In effect, these structures provide convenientseating for closure 154. Steps 158 and 162 are conveniently provided ina downwardly depending skirt 166.

Importantly, inner surface 164 everywhere there is a channel 150, isprovided with a longitudinally extending groove 168 in fluidcommunication with the hollow interior 38 and the channels 150. Anyconvenient number may be chosen as the channels are easily molded intothe end cap when it is formed. The longitudinally extending grooves 168do not extend through the entirety of the wall 140 although they could.They are designed for ease of molding since they can formed in the moldthat makes the plunger without using separate pins to form an opening.This is an important cost consideration in a multiple out high speedmolding process. This structure is designed for preventing the user'sthumb from obstructing the vent opening leading from the interior of theplunger thereby assuring that venting will take place.

Referring now to FIGS. 9 and 12, it will be noted that opening 58 in theback end of barrel 14 includes slots 172 in fluid communication with thehollow interior of the plunger through one or more channels 150 so thatwhen thumb cap 48′ is received in opening 58, no seal is created by thethumb being in contact with opening 58 which might otherwise prevent airfrom venting. The outer periphery of thumb cap 48′ is closely receivedin opening 58 as the syringe is fired, to prevent reuse. Thumb cap 48′is preferably sized in relation to barrel 14 such that opening 58 issimply an extension in a linear direction of the wall of barrel 14rather than enlarged as shown. Finally, the interior surface 164preferably has several annular constrictions 170 designed to catch thehead of stopper 42 during its rearward travel. Since stopper 42 ispreferably installed from the rear of the plunger before closure 154 isput in place, the constrictions 170 must allow stopper 42 to be forcedthrough to the front.

A first alternative thumb cap and closure arrangement is illustrated inFIGS. 13 and 14. In this embodiment, four channels 150 are provided inthumb cap 48″. Closure 174 has four flat side portions 176 spaced aroundthe periphery at 90° intervals, each in fluid communication with achannel 150. A gap is created at each flat side between the flat sides176 and the opening 152′ which are in fluid communication with interior38 to create a flow passage for air from interior 38 through the gapalong the flat side then into channel 150. Annular groove 178 in closure174 may be used to fluidly connect each of the flat areas 176 at thelevel of channels 150. In addition to equalizing air flow, the annulargroove allows venting of air regardless of the angular orientation ofclosure 174 with respect to thumb cap 48″.

A second alternate embodiment has the same thumb cap 48″ with a modifiedclosure 180. Closure 180 has a head 182 which snugly fits within opening152′ which is at the back of the plunger. Opening 152′ is only slightlylarger than the interior of the plunger to provide a seat for theclosure. Four undercut portions 186 are each in joint fluidcommunication with the interior 38 and one of the channels 150 to createa flow passage from the interior 38. Closure 180 effectively seals theopening 152′ so that no fluid particles can escape from the opening. Asin the previous embodiment, an annular groove 178 bridges each undercutportion opening into a corresponding channel 150 thereby tying theundercut portions together in fluid communication regardless of theangular orientation of the parts.

In operation, there are many advantages to the improved combinationdisclosed herein. The diameter of the stopper in both embodiments andthe slidable retaining ring member in the first embodiment, in relationto the diameter across the fluid chamber, makes it possible to produce asyringe which withstands high blowout pressure. By minimizing theeffective surface area exposed to the pressurized fluid during aninjection, the syringe will withstand injection thumb force of aroundfifteen to eighteen pounds during injection and at the same time retractin response to as little as five to six pounds of force on the plungeronce the injection fluid has been injected. Once the fluid has beeninjected, cumulation of force required to concurrently operate theretraction mechanism is avoided. First the stopper is moved back andthen the needle holder is released. By constricting the diameter of thesyringe near a transition zone where the nose begins, a constrictionenables the needle holder to be smaller which in turn allows it to fitin a smaller opening with a smaller stopper in the retraction cavity ofthe hollow plunger.

A vacuum must be pulled in order to fill the syringe. The ring member orthe needle holder, as the case may be, must seal the front nose of thesyringe body because otherwise vacuum could be lost and fluid couldenter the spring area and leak out the front. The hollow outer body andsyringe plunger are preferably made from conventional plastic materialused for syringes, which has some flexibility. The tolerances on thediameter of mating facing surfaces between the head of the needle holderand the barrel and between the stopper and head of the plunger are notcritical in order to maintain a consistent holding and dislodging force.This is believed to be because increasing interference fit increases thefrictional holding force only up to a point and then the surroundingwall simply expands a small amount or the internal parts are compresseda small amount without a corresponding increase in the longitudinalforce required to move the retainer member or plug member in theretraction direction. It is a desirable self correcting mechanism whichis a cost and quality benefit in making the parts. It is believed that aplastic retainer member could be used and the same self limitingfrictional holding force would be obtained.

In the best mode the stopper and the ring member are preferably madefrom a thermoplastic rubber material designated number 181-55 availablefrom Advanced Elastomer Systems, 540 Maryville Centra Drive, St. Louis,Mo. and sold under the trade name Santopreneg. It is said to have acharacteristic hardness around 55 on the Shore A durometer scale whichallows for the right amount of resistance to compression, fluidresistance such that the material does not swell when in contact withmost fluids, environmental stability allowing the friction and sealingproperties to remain non-temperature sensitive, good property retentionafter aging and excellent property retention after sterilization by allaccepted methods. The plunger seal around the head of the plunger isconventional.

The parts are few in number and easily mass produced. The alternateembodiment has the fewest number of separate parts of any tamperproofretractable syringe. The plunger has a one piece hollow outer body witha transition zone and a narrow nose portion. The internal diameter isstepped to greater diameters from front to back for molding around anon-collapsible core which can be extracted from the rear. The same istrue for the plunger.

Assembly is greatly simplified and can be accomplished with high speedmechanized equipment. The needle holder and spring are installable fromthe rear of the barrel without the needle. In the first embodiment theretainer member is forced fit over the inner head of the needle holderand the assembly together with the uncompressed spring are pushedforward and held by sliding engagement of the cooperating inwardly andoutwardly facing surfaces while compressing the spring. The front of theneedle holder passes through an opening in the nose which makes it easyto install the needle from the front by conventional means. Thealternate embodiment is installed the same way except that there is noseparable retainer member around the head of the needle holder.

The narrow nose provides a particular advantage for mechanized assembly.The nose has a wall defining an elongated internal cavity which closelyconfines the spring and needle holder combination. During installationthis cavity serves as a guide to steer the needle holder anduncompressed spring into a compressed state of the spring. This solvesan important assembly problem. If there is much lateral space in thenose around the spring, when the uncompressed spring is beingcompressed, it is a laterally unstable column which flexes sideways andbunches up causing a jam up. It might be added that rounded edges on thebottom of the slot directly below retainer 66 would further facilitateentry of the end of the spring.

The stopper is also installable from the rear of the plunger by pushingit forward until the cooperating lands are slidingly engaged. Then plugmember 50 is force fit or otherwise fixed in the opening at the back ofthe plunger and the plunger is installed in the outer body. It is notnecessary to try to pass the sharp needle through an elongated body withconstricted openings where slight misalignment could cause hangups. Thehead of the needle holder simultaneously acts as a seal as well as aholding device such that no seal is required at the tip of the nose andno ultrasonic welding of separate parts is required.

There is no necessity for using internal locking teeth of any kind. Nolocking teeth are needed to hold the retraction mechanism or to lock theplunger after retraction. Locking teeth present difficult molding andquality control problems, tend to be temperature sensitive and tend torequire a larger diameter barrel which increases premature blowoutproblems. In addition to the non-reusability provided by separation ofthe retainer ring from the head of the needle holder and dislodgement ofthe stopper, the plunger is not accessible after retraction because itis depressed within an opening at the back of the outer body. Thisadditional tamperproof feature is provided in a one piece body withoutthe necessity for hooking anything or twisting anything. The easily madeand installed force fit plug at the back of the retraction cavityprevents access to the retracted components. The Federal government hasrights in the invention under 35 U.S.C. §203. The Federal government hasa nonexclusive, nontransferable irrevocable, paid up license to theinvention as set forth in the priority documents.

1-28. (canceled)
 29. A medical device comprising a needle retractionmechanism disposed inside a body, the needle retraction mechanismcomprising a needle holder grounded against forward movement inside thebody and supporting a forwardly extending needle in fixed relation tothe needle holder, the needle holder comprising a head furthercomprising an inner head supporting the needle in fixed relation to theinner head, and a retainer member surrounding the inner head anddisposed in substantially fixed relation to the inner head prior toretraction, the inner head being biased toward a retraction position bya retraction spring and held in place prior to retraction by attachmentto the retainer member and by contact between the retainer member and aninner wall of the body, the retainer member cooperating with the innerhead to provide a fluid seal between the needle and the body and beingdetachable from the inner head by the application of a retraction forceto the needle holder outwardly of the inner head and in a directioncoaxial to the needle, the retraction force being applied as the resultof forward motion of a plunger relative to the body to initiateretraction, the plunger further comprising a plunger head having asealing element slidably engaging the body, the plunger sealing elementbeing the only structure maintaining the plunger head inside the bodyfollowing retraction.